DRG LARGE SCREW SYSTEM

K973810 · Dolphin Medical Technologies, Inc. · HWC · Jan 5, 1998 · Orthopedic

Device Facts

• Record ID: K973810
• Device Name: DRG LARGE SCREW SYSTEM
• Applicant: Dolphin Medical Technologies, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jan 5, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dolphin Medical Technologies DRG Large Screw™ System will be used on indications that are common with presently marketed devices. The indications for use of the DRG Large Screw™ System reconstruction of intra-anicular epiphyseal and of metaphyseal fractures. Specifically, intracapsular fractures of the hip, slipped capital femoral epiphyses, tibial plateau fractures, distal femoral condyle fractures, ankle, elbow and shoulder fractures where indicated.

Device Story

DRG Large Screw™ System consists of titanium alloy (6AL-4V ELI) bone screws used for fracture fixation and stabilization. Screws are available in 6.5 mm diameter with lengths ranging from 25-120 mm. Device is implanted by surgeons using standard manual orthopedic surgical instruments (stainless steel, ASTM F899-84). Operation involves manual insertion via cannulated hexhead screwdriver. System provides mechanical stabilization of bone fragments to facilitate healing. Used in clinical/surgical settings. Benefits include established clinical performance for fracture fixation based on over 75 years of orthopedic practice.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on established clinical performance of similar bone screw systems used for over 75 years and adherence to voluntary ASTM material and design standards.

Technological Characteristics

Material: Titanium alloy 6AL-4V ELI (ASTM F136-84). Instrumentation: Stainless steel (ASTM F899-84). Design: Cannulated bone screw, 6.5 mm diameter, 25-120 mm lengths. Principle: Mechanical fixation/stabilization. Sterilization: Non-sterile, provided in clean condition for user sterilization.

Indications for Use

Indicated for reconstruction of intra-articular epiphyseal and metaphyseal fractures, including intracapsular hip fractures, slipped capital femoral epiphyses, tibial plateau fractures, distal femoral condyle fractures, and ankle, elbow, and shoulder fractures. Contraindicated for pedicular screw fixation/attachment to the cervical, thoracic, or lumbar spine.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Ace Medical Company (K903810)
• Alphatec Medical (K921622)
• Howmedica (K931524)
• Aesculap (K940207)
• Osteomed (K924018)
• Zimmer (K792022)
• A.O. Synthes (K792291)

Submission Summary (Full Text)

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K973810

Confidential

#### FDA Notification of:

## Summary of Safety and Effectiveness Information Product: DRG Large Screw™ System

# of Safety and Effectiveness Information

### For Release Upon Request Only

### Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

### Company Name / Contact:

| Company: | DMT (DolphinMedical Technologies, Inc.)<br>5959 Cattlemen Lane<br>Sarasota, FL 34232 |
|------------------------------------|-----------------------------------------------------------------------------------------------------|
| Contact: | Regulatory Affairs Department<br>DMT<br>5959 Cattlemen Lane<br>Sarasota, FL 34232<br>[phone] |
| Establishment Registration Number: | Applied for, not received |
| Classification Name: | Smooth or Threaded Bone Fixation<br>Fastener |
| Common Used Name: | Bone Screw |
| Trade Proprietary Name: | DRG Large ScrewTM System |

The FDA has classified similar products as a Class II device by the Orthopedic Device Section of the Surgical and Rehabilitation Devices Panel at Section 888-304. The product code generally refereed to is HWC ( Product Code: HWC ) , and DMT submits this application under this designation.

Section 5 - 1

115

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### FDA Notification of:

### Summary of Safety and Effectiveness Information Product: DRG Large Screw™ System

### Performance Standards:

No performance standards applicable to the Bone Screw have been established by the FDA. However, the titanium alloy 6AL-4V ELI alloy used to manufacture the DMT screws meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84).

#### Package and Labeling:

Package labeling has been developed to industry standards. Packaging is also standard commercially available type quality and is stored in a fashion which prevents damage to the container or package the device is in.

#### System Description:

The DMT DRG Large Screw™ System will be offered in Ti-GAL-4V ELL It will be available in common styles and assorted lengths for bone fraction and stabilization. Initially, a range of twenty-four screw lengths will be made available in 6.5 mm diameter (25-120 mm). Screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwcriver, which is cannulated at center.

#### Indications for Use:

The DMT DRG Large Screw™ System will be used on indications that are common with presently marketed devices. The primary indications for use of the DRG Large Screw™ System are reconstruction of intra-articular epiphysed and of metaphysed fractures. Specifically, intracapeular fractures of the hip, slipped capital femoral epiphyses, tibial platesu fractures, distal femoral condyle frectures, ankle, elbow, and shoulder fractures where indicated. Fixations has been achieved in literally hundreds of thousands of cases with similar predicate devices. Ref. 1.2

Section 5 - 2

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Confidential

# FDA Notification of:

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# Summary of Safety and Effectiveness Information Product: DRG Large Screw™ System

# Substantial Equivalent Devices:

This product is substantially equivalent in design, composition and function to other orthopedic screws manufactured and approved for market.

| Ace Medical Company: | K903810 |
|----------------------|---------|
| Alphatec Medical: | K921622 |
| Howmedica: | K931524 |
| Aesculap: | K940207 |
| Osteomed: | K924018 |
| Zimmer: | K792022 |
| A.O. Synthes | K792291 |

The DMT DRG Large Screw™ System meet the ASTM standards (ASTM B348-83, F136-84, F67-The for material and design for medical application. The bome serews are of the same thread 60) 10. Minutial and length as offered by Synthes, Zimmer, Johnson, Ace, Alphatec and many other orthopaedic companies. The minor and major dismeters as well as the head size are comparable.

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#### FDA Notification of:

## Summary of Safety and II.flectiveness Information Product: DRG Large Screw™ System

#### Instrumentation:

DMT DRG Large Screw™ System instrumentation used for the preparation and insertion of the DRG Large Screws is considered to be general orthopsedic instrumentation. The system includes standard manual orthopedic surgical instruments of the appropriate size and type. All DRG Large Screw™ System instruments are manufactured from stainless steel meeting ASTM F899-84 standards.

#### Product Storilization:

DMT will supply all instruments and implants Non-Sterile. Non-Starile implants are packaged in "clean only" condition. The labeling of the implants and instruments clearly indicates their sterility status. The package insert contains a sterilization/ro-stailization guideline.

#### Summary:

Substantial Equivalence for the DRG Large Screw™ System may be found in comparison with devices from a number of manufactures. Bone Screw systems in general have been used for many years, and the clinical performance is well known and documented.

Another measure of the Safety and Effectiveness of a medical device is how it performs in Jong term use. The basic design concept of bone screws for use in the fixation and stabilization of fractures has had over 75 years of clinical evaluation. Uses, Indications, limitations and surgical techniques are well understood. Standardized manufacturing methods, design practices, material selections and testing techniques are known and represented within the guidelines of this submittal.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 5 1998

Mr. Mark G. Urbanski President & CEO Dolphin Medical Technologies, Inc. 5959 Cattlemen Lane Sarasota, Florida 34232

K973810 Re : DRG Large Screw System Trade Name: Regulatory Class: II Product Code: HWC September 26, 1997 Dated: Received: October 7,1997

Dear Mr. Urbanski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of the Act. This device, if intended for use in pedicular screw fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

- The package insert must prominently state that the device 1 . is intended for the specific use(s) described in the enclosure only; and

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- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the pearcular Berem asses lumbar vertebral column. If this derice is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insent must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." (pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS). for Medical ........ Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

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If you desire specific advice for your device on our labeling
and and the first Book and additionally 809.10 for in If you desire specific advice tor your and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for the regulation (21 CFR Part 801 and addresses the Office of
vitro diagnostic devices), please contact the Office of vitro diagnostic devices), prease contact une on questions on
Compliance at [phone]. Additionally, for questions on Compliance at [phone]. "Address," bour device, please contact
the promotion and advertising of your device, please not the promotion and advertising of your actise, also, please note
the Office of Compliate at [phone]. Also, please note the Office of Compliance ac (505) 330 by reference to the regulation entification" (21 CFR 807.97). Other general premarket notification" (21 cm our the Act may be information on your responsibilities ands - earers Assistance
obtained from the Division of Small Manufacturers [phone] or 2 obtained from the Division of Smart Manufactor [phone] or at
at its toll-free number [phone] or [phone] or at at its toll-free number [phone] or (60%)
its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Confidential

January 2, 1998

Food and Drug Administration Center for Devices and Radiological Health Office of Evaluation Document Mail Center (HFZ-401) 1390 Piccard Drive Rockville, Maryland 20850

K973810 510(k) Application Product: DRG Large Screw™ System

510 (k) No.# :

Device Name: DRG Large Screw™ System

Indications For Use: As listed in the cover letter for this 510(k) application, are as follows:

The Dolphin Medical Technologies DRG Large Screw™ System will be used on indications that are common with presently marketed devices. The indications for use of the DRG Large Screw™ System reconstruction of intra-anicular epiphyseal and of metaphyseal fractures. Specifically, intracapsular fractures of the hip, slipped capital femoral epiphyses, tibial plateau fractures, distal femoral condyle fractures, ankle, elbow and shoulder fractures where indicated.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ..... ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801.109)

Over-The-Counter Use ... . . ........

(Optional Format 1-2-96)